I prodotti biosimilari nel mercato delle gonadotropine

Autori: Enrica Maria Proli

After the recent launch in Italy of Ovaleap® and Bemfola®, (follitropin alfa, r hFSH) two recombinant human follicle-stimulating hormone biosimilars, we analyze how market features and public policies try to regulate their entry, market prices, and penetration. Ovaleap® and Bemfola® are biosimilar products for a fertility treatment for anovulation, stimulation of follicular development and spermatogenesis, which has been approved by the European Medicines Agency (EMA) e by AIFA, the Italian Agency for Medicine. They are biosimilar to Gonal-f® (follitropin alfa, r-hFSH) from Merck Serono. It has the same indication and comparable efficacy and safety profile. Ovaleap® is administered via a re-useable self-injection pen – the Ovaleap® Pen – which can hold three different cartridge sizes (300 IU, 450 IU and 900 IU) while Bemfola® is administered via a non re-usable self-injection pen and different sizes (75 IU, 150 IU, 225 IU, 300 IU, 450 IU).

These differences could be appreciated by contracting authorities together other elements as medical devices, supplies or services intended for use by natural persons. The Italian regions have adopted legislative measures to encourage the use of biosimilars, particularly in naive patients, but none defined these patient before the treatment plan for assisted reproductive technologies, when, at the end of the controlled ovarian stimulation phase with injectable gonadotropins, a single injection of human chorionic gonadotropin may be used to promote final follicular maturation and to trigger ovulation.

Up to now in Italy for these products’ negotiations and contracts on the basis of the best price-quality ratio, which is most suitable for comparing tenders for innovative solutions, were not yet used, but only on the basis of best price.

We consider the instrument of framework agreements has been widely used and is considered as an efficient procurement technique, particularly for these products characterized by at production system level differences, medical device of administration and related service.


ovaleap, Bemfola, biosimilars, framework agreeement.


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